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Pristiq (Desvenlafaxine Succinate) - Summary

 
 



WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Pristiq or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Pristiq is not approved for use in pediatric patients [ see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 ), and Patient Counseling Information ( 17.1 ) ].

 

PRISTIQ SUMMARY

MEDICATION GUIDE

Pristiq is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O‑desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive, generalized anxiety, social anxiety and panic disorders.

Pristiq, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [ see Clinical Studies (14) and Dosage and Administration (2.1) ]. The efficacy of Pristiq has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder.

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.


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NEWS HIGHLIGHTS

Media Articles Related to Pristiq (Desvenlafaxine)

Boys and girls who mature early are at higher risk of several adverse outcomes, including depression
Source: Anxiety / Stress News From Medical News Today [2014.11.22]
Youth who enter puberty ahead of their peers are at heightened risk of depression, although the disease develops differently in girls than in boys, a new study suggests.

Postpartum depression: citalopram benefits explained
Source: Depression News From Medical News Today [2014.11.21]
Researchers believe they have found why the commonly prescribed antidepressant drug citalopram is effective in relieving postpartum depression.

Stress and Depression Mediated by Single Brain Protein
Source: Medscape Psychiatry & Mental Health Headlines [2014.11.20]
Beta-catenin plays a central role in resilience to stress and susceptibility to depression, potentially offering novel therapeutic targets, say US scientists.
Medscape Medical News

Job authority may increase depression symptoms in women
Source: Anxiety / Stress News From Medical News Today [2014.11.20]
Women in authoritative job positions have more depression symptoms than those not in such positions, a new study finds. But for men, job authority may reduce depression symptoms.

How the brain manages stress suggests new model of depression
Source: Anxiety / Stress News From Medical News Today [2014.11.16]
Discovery of new molecular and behavioural connections may provide a foundation for the development of new treatments to combat some forms of depressionThe brain's ability to effectively deal...

more news >>

Published Studies Related to Pristiq (Desvenlafaxine)

Randomized placebo- and active-controlled study of desvenlafaxine for menopausal vasomotor symptoms. [2011.11.08]
ABSTRACT Objective To evaluate the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) vs... Adverse drug reactions were consistent with the known safety profile of desvenlafaxine, and significantly more women who received tibolone experienced episodes of bleeding compared with women who received desvenlafaxine or placebo.

Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram. [2011.03.01]
BACKGROUND: Preliminary clinical evidence indicates that menopausal status might impact on the efficacy of certain classes of antidepressants. OBJECTIVE: The aim of this study was to evaluate open-label desvenlafaxine treatment (administered as desvenlafaxine succinate) in postmenopausal women who did not achieve clinical response to acute, double-blind treatment with desvenlafaxine or escitalopram... CONCLUSIONS: Postmenopausal women with major depressive disorder who did not respond to acute, double-blind treatment with escitalopram or desvenlafaxine achieved modest, continued improvement with long-term, open-label desvenlafaxine therapy. Further interpretation of these findings is limited by aspects of the study design (i.e. open-label, non-placebo-controlled) and the lack of randomized comparison groups in the extension phase, which prevents statistical assessment of the efficacy of longer term treatment with desvenlafaxine. Clinicaltrials.gov identifier: NCT00406640.

Pharmacokinetics of venlafaxine extended release 75 mg and desvenlafaxine 50 mg in healthy CYP2D6 extensive and poor metabolizers: a randomized, open-label, two-period, parallel-group, crossover study. [2011]
BACKGROUND: Genetically driven variations in the level of cytochrome P450 (CYP) 2D6 metabolic activity have been shown to significantly affect the pharmacokinetic behaviour of medications that are substrates of this enzyme. OBJECTIVE: To evaluate the impact of CYP2D6 extensive metabolizer (EM) and poor metabolizer (PM) phenotypes on the pharmacokinetics of single doses of venlafaxine extended release (ER) and desvenlafaxine (administered as desvenlafaxine succinate)... CONCLUSION: In contrast to venlafaxine ER 75 mg, the pharmacokinetics of desvenlafaxine 50 mg is not significantly impacted by CYP2D6 genetic polymorphisms. PMs receiving venlafaxine ER 75 mg had significantly lower O-desmethylvenlafaxine and higher venlafaxine plasma concentrations.

Clinical outcomes following switch from venlafaxine ER to desvenlafaxine in nonresponders and responders. [2011]
CONCLUSIONS: Among nonresponders to 8 weeks of double-blind venlafaxine ER,

Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. [2010.08]
CONCLUSIONS: Short-term treatment with desvenlafaxine was effective and generally well tolerated in perimenopausal and postmenopausal women with MDD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00369343. Copyright 2010 Physicians Postgraduate Press, Inc.

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Clinical Trials Related to Pristiq (Desvenlafaxine)

12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder [Recruiting]

Desvenlafaxine vs. Placebo Treatment of Chronic Depression [Recruiting]
The investigators are studying a new antidepressant medicine, desvenlafaxine, for the treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been approved by the FDA for the treatment of major depression.

The investigators are testing whether this medicine is also effective for adults with a type of chronic depression that is less severe than major depression. This condition is also known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years, often causes significant suffering and impairment.

In addition, the investigators are using MRI imaging, which uses magnetic signals to make pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in this study is to see whether chronic depression is associated with differences in brain structure or functioning, and whether such differences change after medication or placebo treatment. To test this MRI scans are done at the start of the study and after 12 weeks of medication or placebo treatment. Getting MRI imaging will be an option for participants in this study but is not required.

This study involves a 6 to 12 week double-blind period during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved antidepressant medication.

Assessments (of depressive symptoms, social functioning, and personality) will be done by study staff and by patients before the study starts, at each study visit for the first 12 weeks, and again after 24 weeks in the study.

Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet [Recruiting]
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.

Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients [Recruiting]
This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipino patients with MDD and VMS per usual clinical practice within the first three years post commercial distribution.

Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR) [Recruiting]

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Reports of Suspected Pristiq (Desvenlafaxine) Side Effects

Drug Ineffective (223)Nausea (202)Depression (198)Dizziness (180)Anxiety (168)Feeling Abnormal (158)Malaise (157)Headache (146)Insomnia (128)Withdrawal Syndrome (117)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 11 ratings/reviews, Pristiq has an overall score of 7.27. The effectiveness score is 7.82 and the side effect score is 7.45. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Pristiq review by 52 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Depression
Dosage & duration:   50mg taken once daily for the period of I have been taking this drug for 6 month
Other conditions:   anxiety
Other drugs taken:   xanax
  
Reported Results
Benefits:   This is an NSRI, different from an SSRI because it works on more than one brain chemical. When an SSRI is ineffective or a patient finds that after a period of time a working drug stops working and symptoms of depression return they may be advised to try an NSRI. This was the case with me. I have been treated for my depression for years and had done extremely well for periods of time on several different drugs at different times. Moving from one to the next as I bottomed out on each. Celexa and Lexapro being the most recent. When Lexapro let me down after a couple of years I was advised to try Pristiq which was just released only a few months before my doctor suggested it. I was extremely hesitant as I did not want to go through another adjustment period of sleeplessness, headaches, possible weight gain, sexual issues, etc. You know the drill if you have taken drugs for deperession. So I chose to stay on my Lexapro and be depressed, hoping that it would start working again at a higher dose. Wrong. Getting to the end of my rope with my depression I finally decided to bite the bullet and try the Prestiq. My depression disappeared within 3 weeks leaving me feeling better than I had in months. I began smiling again and fully functioning doing the things I enjoy and had let slide. My sense of well being and hopefulness for the future returned.
Side effects:   Honestly, none for me. I sleep, did not gain an ounce, in fact I lost a small amount of weight even though I did not need to, no sexual side effect at all! Only thing that was tough was waiting for the dosage level to become theraputic in my system, which as I mentioned took about 3 weeks.
Comments:   I was instructed to continue on the Lexapro at a lower dose for one week. At the 2nd week add my dose of Pristiq to the lower dose of Lexapro, at the 3rd week drop the Lexapro completely and continue on my dose of Pristiq. This was done while staying in contact with my prescribing doctor. Now I take 1 50mg tablet everyday of Pristiq, and am doing very well.

 

Pristiq review by 47 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   40 mg taken once daily for the period of two years
Other conditions:   ADHD
Other drugs taken:   Vyvanse
  
Reported Results
Benefits:   Pristiq elevated mood and energy levels.
Side effects:   Increased anxiety
Comments:   Pristiq was prescribed at a 20 mg dose and then increased to 40 mg dose. I continue to take it as it has been the most effective medication for alleviating symptoms of depression that I have tried, including Prozac, Effexor, Wellbutrin and Lexapro.

 

Pristiq review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   severe depression
Dosage & duration:   50mg taken 50 mg once daily for the period of little more than 2 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I had no benefits
Side effects:   Nausea, dizziness, increased anxiety, and extreme irritibility.
Comments:   I could not control my irritability. It was out of control. I felt like I was not myself. When starting my third week on this med, I stopped. By day two I felt much better. Would not try this drug again. Had only slight nausea after stopping this medications that quickly went away. My depression worsened on this med. Would not recommend.

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Page last updated: 2014-11-22

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